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      Preclinical Rationale for the Phase III Trials in Metastatic Pancreatic Cancer: Is Wishful Thinking Clouding Successful Drug Development for Pancreatic Cancer?

      research-article
      , MBBS, , MBBS, , MD *
      Pancreas
      Preclinical evidence, metastatic pancreatic cancer, randomized phase III trials

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          Abstract

          Prior phase III trials in advanced pancreatic cancer have been predominantly unsuccessful. In this review we attempt to understand how past preclinical data was translated into phase III clinical trials in metastatic pancreatic cancer as described in the paper. A systematic literature review conducted through the MEDLINE, EMBASE, and Cochrane Centre Register of Controlled Trials databases, from January 1997 to June 2015 using key words - phase III clinical trials, metastatic/advanced pancreatic adenocarcinoma or pancreatic cancer identified 30 randomized controlled trials (RCTs) that met criteria. The trials were limited to RCTs in the first-line treatment of patients with metastatic pancreatic cancer. The success rate of first-line phase III studies in advanced pancreatic cancer was only 13%. In 60% of the RCT’s, no preclinical experiments were referenced in biologically cognate pancreatic models. Nine (30%) of the RCTs were designed based on preclinical evidence from in vitro cell lines alone without additional in vivo validation in xenograft models. It remains uncertain how strongly the preclinical data influences the development of clinical regimens but so far the studies developed based on more solid preclinical evidence have been successful.

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          Author and article information

          Contributors
          Journal
          8608542
          6627
          Pancreas
          Pancreas
          Pancreas
          0885-3177
          1536-4828
          17 November 2016
          February 2017
          01 February 2018
          : 46
          : 2
          : 143-150
          Affiliations
          Division of Hematology/Oncology, Vanderbilt University, Nashville, TN
          Sheikh Ahmed Pancreatic Cancer Research Center, Departments of Pathology and Translational, Molecular Pathology, MD Anderson Cancer Center, Houston, TX
          Division of Hematology/Oncology, Vanderbilt University, Nashville, TN
          Author notes
          [* ] Corresponding author: Jordan Berlin, MD, Ingram Professor of Cancer Research, Co-Director, GI Oncology, Director, Phase I research, 2220 Pierce Ave # 777, Nashville, TN 37232, jordan.berlin@ 123456vanderbilt.edu , Phone: 615-343-4128, Fax: 615-343-7602
          Article
          PMC5242389 PMC5242389 5242389 nihpa827912
          10.1097/MPA.0000000000000753
          5242389
          28085753
          966412c3-af41-4309-b848-ddb33f8a0600
          History
          Categories
          Article

          randomized phase III trials,metastatic pancreatic cancer,Preclinical evidence

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